News Ticker

A Drug Recall That Should Frighten Us All About The FDA

PHOTO: The Ring of Fire/Youtube

By David Maris | 10 October 2012

FORBES — Pay attention, as I can’t say this seriously enough. Last week, the FDA took a drug off the market, and the reasons should send shivers of fear down the backs of consumers, investors, generic drug companies – and the FDA.

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories IPXL +0% and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also. With this generic, American consumers became the FDA’s guinea pigs to see if the FDA’s assumption was right. It wasn’t. […]

2 Comments on A Drug Recall That Should Frighten Us All About The FDA

  1. This reads like a setup by the FDA to discredit generic drug manufactures by letting them run wild with no oversight for more than a decade, then selectively (and S-L-O-W-L-Y) raising the curtain on rot and ruin that grew like mold in the absence of adult supervision.
    Why are the former heads of the FDA in chains doing a PERP walk in front of prestige press cameras? (because its not a mistake?)

  2. >With this generic

    With ‘globalization’, once the original patent expires a ‘generic’ drug can be manufactured pretty much anywhere; and as for other manufactured items/goods, the cheaper the better — this means manufacturing in places like India and China, where controls are lax and moral standards often even laxer (i.e. it’s a bit unfair to view this as primarily an FDA problem):

    Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA

    In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA Inc. , a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty today to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India, …

    FDA bans imports from Sun Pharma plant in India crackdown

    The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories IPXL …

    Impax was acquired by Amneal; here’s what Wikpedia says about Amneal (link): Amneal Pharmaceuticals was founded in 2002 by brothers Chirag and Chintu Patel.

    I would not trust these companies.

Post a Comment

%d bloggers like this: